Panacea
AI-Native FDA Regulatory Services
Panacea operates in healthcare based in San Francisco, CA, USA, founded in 2008.
Profile
Panacea provides AI-native FDA regulatory services for Biotechs and Medical Device companies. We hire the most experienced FDA consultants in the industry (ex-FDA, decades of experience, hundreds of filings) and pair them with our AI platform to enable the fastest and lowest cost pathway to FDA approval.
While other regulatory consultants bill hourly, our pricing model is simple: fixed, outcome-based pricing. Payment is only due when milestones are complete.
We support all FDA regulatory pathways including IND, NDA, BLA, ODD, Pre-Subs, 510(k), De Novo, PMA, IDE, BDD, etc.
Panacea is positioned in healthcare, a segment that rewards a clear, focused offering.
The business is associated with San Francisco, CA, USA.
The company is listed at the Spring 2026 stage of development.
Recorded headcount: 2 employees.
Directory analysis
Panacea offers AI‑native FDA regulatory services to biotech and medical device companies, combining experienced FDA consultants with an AI platform to accelerate approval processes. The firm covers all FDA pathways, including IND, NDA, BLA, 510(k), De Novo, and PMA, among others. It charges a fixed, outcome‑based fee, payable only upon milestone completion.
Positioning: Panacea positions itself as a cost‑efficient alternative to traditional hourly regulatory consulting, leveraging AI to streamline submissions. Its niche focus on FDA pathways could appeal to companies seeking faster, predictable regulatory outcomes.
Note: Panacea provides fixed, outcome‑based pricing for FDA regulatory services.
Auto-generated directory analysis from public data · updated 6 Oct 2026. Informational only, not investment advice.
| Sector | Healthcare |
|---|---|
| Headquarters | San Francisco, CA, USA |
| Country | USA |
| Founded | 2008 |
| Employees | 2 |
| Stage | Spring 2026 |
Website: withpanacea.com
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